| Journal: | Brazilian Journal of Pharmaceutical Sciences |
| Database: | PERIÓDICA |
| System number: | 000451532 |
| ISSN: | 1984-8250 |
| Authors: | Castro, Jaqueline Cristina da Silveira Xavier e1 Botelho, Stephanie Ferreira2 Martins, Maria Auxiliadora Parreiras3 Vieira, Liliana Batista4 Reis, Adriano Max Moreira3 |
| Institutions: | 1Universidade Federal de Minas Gerais, Hospital das Clinicas, Belo Horizonte, Minas Gerais. Brasil 2Secretaria de Estado da Saude de Minas Gerais, Diretoria de Medicamentos Estrategicos, Belo Horizonte, Minas Gerais. Brasil 3Universidade Federal de Minas Gerais, Faculdade de Farmacia, Belo Horizonte, Minas Gerais. Brasil 4Universidade Federal de Alfenas, Faculdade de Ciencias Farmaceuticas, Alfenas, Minas Gerais. Brasil |
| Year: | 2021 |
| Volumen: | 57 |
| Country: | Brasil |
| Language: | Inglés |
| Document type: | Artículo |
| Approach: | Analítico, descriptivo |
| English abstract | This study aims to analyze the new drugs registered in Brazil from 2003 to 2013 from the perspective of childcare needs, drug safety and considering the disease burden of the country. This is a retrospective cohort study including new drugs registered in Brazil between 2003 and 2013. Drug indications were related to the Disability-Adjusted Life Year (DALY) of the 2015 Global Burden of Disease Study. Association between the number of new drugs and DALY was determined by Spearman’s coefficient. Post-marketing safety alerts specific to the pediatric population have been identified in the WHO Drug Information Bulletin and on websites of drug regulatory agencies. A total of 134 new drugs were included in the cohort and 46 (34.3%) had a pediatric indication. There was no evidence of an association between the disease burden in children in Brazil and the number of pediatric drugs. The safety alert data associated with the pediatric population published after registration of the new drugs were scarce. The number of new drugs launched in Brazil with a pediatric indication was small, reflecting the international challenges of developing effective and safe medicines for children. No association was found between the number of new drugs and the disease burden |
| Disciplines: | Medicina |
| Keyword: | Farmacología, Salud pública, Pediatría, Nuevos medicamentos, Vigilancia farmacológica, Carga de enfermedad |
| Keyword: | Pharmacology, Public health, Pediatrics, New drugs, Pharmacological surveillance, Disease burden |
| Full text: | Texto completo (Ver HTML) Texto completo (Ver PDF) |
